Check your device against FDA’s own database. Free.
We'll identify your likely FDA class, candidate product codes, and predicate devices you could file against.
- Cost
- Free, always
- What you send
- A link, or a sentence
- Checked against
- FDA's own databases
- You get it back
- in about two minutes
- Delivered
- By email, yours to keep
- Obligation
- None
How it works
- Tell us about your device — a link to its product page, or a short description if it isn't public yet.
- We check it against FDA's classification database, past 510(k) clearances, and predicate devices in your category.
- You get your likely class, candidate product codes, and predicates in about two minutes — by email.
No account, no payment details, and no obligation. If you would rather talk it through first, you can talk to a regulatory expert instead.
What you get
| Your likely FDA device class | Class I, II or III |
|---|---|
| Candidate product codes, with the regulation behind each | Three-letter code + 21 CFR cite |
| Predicate devices you could file against | Cleared devices, with K-numbers |
Questions people ask
Is the device check really free?
Yes. There's no cost and no obligation — you get your results whether or not you ever become a client.
What do I need to provide?
A link to your device's product page, or a short description if it isn't public yet — plus its intended use. That's enough for us to search it against FDA's own classification and 510(k) databases.
How long does it take to get results?
Most results are ready in about two minutes.
Is this the same as the Gap Assessment?
No. This tells you your likely class, product code, and predicates. The Gap Assessment goes further — it reviews your actual documents and tells you what closing the difference to a full submission would cost.
What happens after I get my results?
Nothing, unless you want it to. You can book time with a regulatory expert to talk through what they mean, or just keep the report.